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      Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya

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          Abstract

          Objective

          To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice.

          Materials and methods

          The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals’ pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals.

          Results

          In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use.

          Conclusion

          A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research.

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          Most cited references27

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          Challenges for Routine Health System Data Management in a Large Public Programme to Prevent Mother-to-Child HIV Transmission in South Africa

          Background Recent changes to South Africa's prevention of mother-to-child transmission of HIV (PMTCT) guidelines have raised hope that the national goal of reducing perinatal HIV transmission rates to less than 5% can be attained. While programmatic efforts to reach this target are underway, obtaining complete and accurate data from clinical sites to track progress presents a major challenge. We assessed the completeness and accuracy of routine PMTCT data submitted to the district health information system (DHIS) in three districts of Kwazulu-Natal province, South Africa. Methodology/Principal Findings We surveyed the completeness and accuracy of data reported for six key PMTCT data elements between January and December 2007 from all 316 clinics and hospitals in three districts. Through visits to randomly selected sites, we reconstructed reports for the same six PMTCT data elements from clinic registers and assessed accuracy of the monthly reports previously submitted to the DHIS. Data elements were reported only 50.3% of the time and were “accurate” (i.e. within 10% of reconstructed values) 12.8% of the time. The data element “Antenatal Clients Tested for HIV” was the most accurate data element (i.e. consistent with the reconstructed value) 19.8% of the time, while “HIV PCR testing of baby born to HIV positive mother” was the least accurate with only 5.3% of clinics meeting the definition of accuracy. Conclusions/Significance Data collected and reported in the public health system across three large, high HIV-prevalence Districts was neither complete nor accurate enough to track process performance or outcomes for PMTCT care. Systematic data evaluation can determine the magnitude of the data reporting failure and guide site-specific improvements in data management. Solutions are currently being developed and tested to improve data quality.
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            Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations.

            E Hannan (2008)
            The 2 primary types of studies that are used to test new drugs or procedures or compare competing drugs or types of procedures are randomized clinical trials (RCTs) and observational studies (OS). Although it would appear that RCTs always trump OS because they eliminate selection bias, there are many possible limitations to both types of studies, and these limitations must be carefully assessed when comparing the results of RCTs and OS. This state-of-the art review describes these limitations and discusses how to assess the validity of RCTs and OS that yield different conclusions regarding the relative merit of competing treatments/interventions.
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              Design and implementation of a health management information system in Malawi: issues, innovations and results.

              As in many developing countries, lack of reliable data and grossly inadequate appreciation and use of available information in planning and management of health services were two main weaknesses of the health information systems in Malawi. Malawi began strengthening its health management information system with an analysis of the strengths and weaknesses of existing information systems, sharing findings with all stakeholders. All were agreed on the need for reformation of various, vertical programme-specific information systems into a comprehensive, integrated, decentralized and action-oriented simple system. As a first step towards conceptualization and design of the system, a minimum set of indicators was identified and a strategy was formulated for establishing a system in the country. The design focused only on the use of information in planning, management and the improvement of quality and coverage of services. All health and support personnel were trained, employing a training of trainers cascade approach. Information management and use was incorporated into the pre-service training curriculum and the job description of all health workers and support personnel. Quarterly feedback, supportive supervision visits and annual reviews were institutionalized. Civil society organizations were involved in monitoring coverage of health services at local levels. A mid-term review of the achievements of the health information system judged it to be one of the best in Africa. For the first time in Malawi, the health sector has information by facility by month. Yet very little improvement has been noted in use of information in rationalizing decisions. The conclusion is that, no matter how good the design of an information system, it will not be effective unless there is internal desire, dedication and commitment of leadership to have an effective and efficient health service management system.
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                Author and article information

                Journal
                9430800
                20222
                J Am Med Inform Assoc
                J Am Med Inform Assoc
                Journal of the American Medical Informatics Association : JAMIA
                1067-5027
                1527-974X
                10 September 2015
                10 June 2015
                January 2016
                29 February 2016
                : 23
                : 1
                : 184-192
                Affiliations
                [1 ]KEMRI-Wellcome Trust Research Programme, P. O. Box 43640 - 00100, Nairobi, Kenya
                [2 ]Nuffield Department of Medicine, University of Oxford John Radcliffe Hospital, Headington, Oxford, OX3 9DU, UK
                Author notes
                [* ]Correspondence to Timothy Tuti KEMRI-Wellcome Trust Research Programme, P. O. Box 43640 - 00100, Nairobi, Kenya; TTuti@ 123456kemri-wellcome.org

                CONTRIBUTORS

                The roles of the contributors were as follows: T.T., and M.B. drafted with the help of M.E. an initial version of this manuscript. All authors contributed to subsequent drafts and approved a final version of this paper.

                The Clinical Information Network members who contributed to the conduct of the work, collection of data, data quality assurance and development of data management and reporting frameworks that form the basis of this report include: Wycliffe Nyachiro, George Mbevi, and Morris Ogero.

                Article
                EMS65061
                10.1093/jamia/ocv028
                4681113
                26063746
                febac55d-22bf-4167-ad5f-a4ef2da8efe6

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Article

                Bioinformatics & Computational biology
                clinical data management,open source,clinical research,quality assurance,metaprogramming

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